# K983543: Accu-Pulse 1000 CO2 Surgical Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Argus Photonics Group
- Decided: Dec 16, 1998 after 68 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K952049 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971830: Accu-Pulse Carbon Dioxide Laser System, Argus Photonics Group (1997) Summary page 3.

## Indications for use
For use in cutting, vaporizing and coagulating soft tissue for clinical applications in dermatology, plastic surgery, podiatry, neurosurgery, gynecology, otorhinolaryngology, arthroscopy, open & endoscopic general surgery.

Source page: https://510kreport.com/device/K983543
Methodology: https://510kreport.com/methodology